Gefitinib

Orange BookUNIISPLATC L01EB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01EB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480405356
30 TABLET, FILM COATED in 1 BOTTLE (0480-4053-56)

Annotations

UNII (FDA Substance ID)

S65743JHBS

GEFITINIB

RxCUI 328134

Orange Book

A208913

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "S65743JHBS",
    "rxcui": "328134",
    "inchikey": "XGALLCVXEZPNRQ-UHFFFAOYSA-N",
    "display_name": "GEFITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1a3c0ce7-06a1-4e04-9106-14ddb2a866a5": {
      "match": "brand_token",
      "title": "GEFITINIB TABLET, FILM COATED [NATCO PHARMA USA LLC]",
      "spl_version": "4",
      "published_date": "2026-03-11"
    }
  },
  "productid": "0480-4053_94ce2dc4-2b69-4c50-b53e-21e24062903d",
  "productndc": "0480-4053",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208913",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEFITINIB",
  "proprietary_name": "Gefitinib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208913",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gefitinib",
  "start_marketing_date": "20230621",
  "active_numerator_strength": "250"
}

Related drugs

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